DKMAnet - Prices & Packages - questions and answers
I have problems with making a notification via DKMAnet – Prices & Packages – what should I do?
If you have problems with notifying changes in price and product range via DKMAnet – Prices & Packages, please contact DKMAnet Support IMMEDIATELY on +45 4488 9694. Our telephone line is open daily from 9:30 to 15:00, however, on notification Mondays, the line is open until 16:30.
If you have problems with making a notification on a Monday after 16:30, please submit your notification by email to email@example.com before 20:00.
You must state in your email, why you have not submitted the notification electronically and attach a screen dump of the error that occurred when you tried to submit your notification via DKMAnet.
We will accept your notification by email if the submission problem on DKMAnet was caused by an error in the Danish Health and Medicines Authority's systems. We will assess whether or not your email notification should be accepted on Tuesday mornings.
Which medicine information can I see in Prices & Packages?
In Prices & Packages, you will have access to information on the registrable medicines and packages which you market or have authorisation to market in Denmark.
The lists in Prices & Packages will state the following information for each created package:
- Product number
- Name of medicine
- Drug form
- Package size
- AIP (apotekets indkøbspris – pharmacy purchase price) for the selected price period
- Market situation (i.e. is the package marketed now or is it temporarily withdrawn from the market)
The list in Prices & Packages will show the following information for each authorised medicine (not in quarantine):
- Name of medicine
- Drug form
- MA number/record number
Can I deregister a medicine on DKMAnet – Prices & Packages?
It is possible to deregister a medicine via DKMAnet – Prices & Packages. However, if you do not wish to deregister the medicine, but just wish to withdraw one or more packages from Medicine Prices temporarily (deactivation) or delete an individual package from the product range (the package will be marked as deleted and cannot be marketed again at a later date), you can do this on DKMAnet – Prices & Packages.
Please note that even though you have deleted all packages linked to a medicine, you will still need to deregister the medicine.
We are resuming marketing of a medicine, why is the upload of the package leaflet unsuccessful?
You must change the status to ‘Marketed’ before you can upload a new package leaflet.
Who is responsible for uploading package leaflets to DKMAnet – Package Leaflets?
The marketing authorisation holder (MAH) is responsible for uploading package leaflets to DKMAnet - Package Leaflets.
In the following, we refer to the person/entity handling package leaflets on DKMAnet – Package Leaflets as the ‘company’ regardless of whether this is a representative or the actual MAH.
Must a company notify long-term changes in marketing status on DKMAnet - Package Leaflets?
The company is responsible for changing the status of a medicine to ‘Not marketed’ in connection with long-term cessation of the marketing of a product when this is not caused by deregistration or suspension of marketing authorisation.
A change of marketing status on DKMAnet - Package Leaflets will only be used in relation to DKMAnet - Package Leaflets and thus indlaegesseddel.dk. In other words, it is not considered a notification in the meaning of the Danish Medicines Act, which provides that companies are required to notify changes in marketing status to the Danish Health and Medicines Authority.
For how long is a package leaflet visible on indlaegseddel.dk after a change of status to “Not marketed”?
The package leaflet will remain on the website for 180 days after the company has changed the status of a medicine to ‘Not marketed’.
This is also the case for the package leaflet of a medicine which may no longer be marketed legally. However, in this case the medicine will no longer be visible on DKMAnet – Package Leaflets.
Who is responsible for notifications to Prices & Packages?
Electronic notification implies that no data are manually entered by the Danish Medicines Agency, and the employees of the Agency have no possibilities of making notifications to Prices & Packages on behalf of the companies.
This way, it is ensured that only the company can influence the notification data.
It is important to note that all the notifications that the company administrator or appointed company users make on behalf of the company via Prices & Packages are binding on the company. If the company administrator creates company users outside the company, the company has sole responsibility for arranging the necessary agreements.
The Danish Health and Medicines Authority does not check the company administrator's creation of company users.
If a company represents more than one marketing authorisation holder (MAH), how is that handled?
If a company is a representative for more than one MAH, the company gains access to the MAH's product ranges, using its company number. This means that the medicine packages of the respective MAHs will be displayed in one list in Prices & Packages.